The purpose of this study is to evaluate the efficacy and safety of MK-3102 in participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency or end stage renal disease on dialysis with inadequate glycemic control. The primary hypothesis of the study is that MK-3102 compared to placebo produces greater reduction in glycosylated hemoglobin (A1C) after 24 weeks.

A Phase III, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects With Type 2 Diabetes Mellitus With Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control

Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Baseline to Week 24 (up to 24 weeks) ] [ Designated as safety issue: Yes ]

Percentage of participants who experienced at least one adverse event [ Time Frame: Baseline up to 28 days following the last dose of study therapy (up to 58 weeks) ] [ Designated as safety issue: Yes ]

Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Baseline to Week 54 (up to 54 weeks) ] [ Designated as safety issue: Yes ]

MK-3102 12.5 mg or 25 mg capsule orally once a week for 54 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24), will receive matching placebo to glipizide in a blinded manner during Phase B of the study (Week 24 through Week 54).

Drug: MK-3102

Participants with moderate renal insufficiency will receive one MK-3102 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one MK-3102 12.5 mg capsule orally once a week

Drug: Glipizide

Participants may receive open-label glipizide as rescue therapy during Phase A (up to Week 24) of the study. During Phase B of the study (after Week 24), participants who did not receive insulin or open-label glipizide rescue therapy during Phase A will receive glipizide 2.5 mg or 5 mg capsule or matching placebo as blinded therapy at a starting dose of 2.5 mg once daily in the morning prior to the morning meal and electively titrated up to a maximum of 20 mg/day based on glycemic control.

Other Names:

Glucotrol

Glucotrol XL

Drug: Placebo to glipizide

Matching placebo to glipizide

Biological: Insulin

Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.

Placebo Comparator: Placebo to MK-3102

Matching placebo to MK-3102 orally once a week for 54 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24), will receive glipizide in a blinded manner during Phase B of the study (Week 24 through Week 54).

Drug: Placebo to MK-3102

Matching placebo to MK-3102 capsule administered orally once a week

Drug: Glipizide

Participants may receive open-label glipizide as rescue therapy during Phase A (up to Week 24) of the study. During Phase B of the study (after Week 24), participants who did not receive insulin or open-label glipizide rescue therapy during Phase A will receive glipizide 2.5 mg or 5 mg capsule or matching placebo as blinded therapy at a starting dose of 2.5 mg once daily in the morning prior to the morning meal and electively titrated up to a maximum of 20 mg/day based on glycemic control.

Other Names:

Glucotrol

Glucotrol XL

Drug: Placebo to glipizide

Matching placebo to glipizide

Biological: Insulin

Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.

Eligibility

Ages Eligible for Study:

30 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus and be at least 30 years of age

Moderate or severe chronic renal insufficiency or end stage renal disease on dialysis

Meet one of the following criteria:

is currently not on an antihyperglycemic agent (AHA) and has A1C >=7% and <=10% at screening

is currently on a single oral AHA or low-dose dual oral combination AHA and has A1C >=6.5% and <=9% at screening

is currently on a stable insulin regimen (>= 15 U/day) for >= 10 weeks, with no oral AHA, and has A1C >=7.5% and <=10% and FPG >130 mg/dL at screening

(1) Male; (2) female not of reproductive potential; or (3) female of reproductive potential who agrees to remain abstinent or use alone or in conjunction with their partner 2 methods of contraception to prevent pregnancy during the study and for 28 days after the last dose of study drug

Exclusion Criteria:

History of type 1 diabetes mellitus or a history of ketoacidosis

Treated with any incretin mimetic or thiazolidinedione (TZD) within 12 weeks prior to screening or with MK-3102 at any time prior to study participation

History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor

History of intolerance or hypersensitivity to glipizide or insulin glargine or any contraindication to glipizide or insulin glargine

On a weight loss program and is not in the maintenance phase, or has been on a weight loss medication in the past 6 months, or has undergone bariatric surgery within 12 months prior to study participation

Undergone a surgical procedure within 4 weeks prior to screening or has planned major surgery during the trial

On or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal or topical corticosteroids are permitted)

Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks

If on dialysis, does not regularly adhere to dialysis schedule

Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class IV

Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the trial, including 28 days following the last dose of study drug

User of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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